This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
California Pacific Medical Center Van Ness/Sutter Health
Primary Effectiveness Endpoint
Revascularization rate post-index procedure of target treatment area determined by an independent core lab.
Time frame: Immediately Following Index Procedure
Primary Safety Endpoint
Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor.
Time frame: 48 Hours
Distal embolization SAEs
Time frame: Intra-procedure
All-cause mortality
Time frame: 1-month follow-up visit
Limb salvage
Freedom from major amputation of the index limb
Time frame: 1-month follow-up visit
Amputation-free survival
Freedom from major amputation and all-cause mortality
Time frame: 1-month follow-up visit
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San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
RECRUITINGMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGAscension Sacred Heart Pensacola
Pensacola, Florida, United States
RECRUITINGTerrebonne General Hospital/Cardiovascular Institute of the South
Houma, Louisiana, United States
RECRUITINGMass General Hospital
Boston, Massachusetts, United States
RECRUITINGMyMichigan Health
Midland, Michigan, United States
RECRUITINGCooper University Hospital
Camden, New Jersey, United States
RECRUITINGNYP-Brooklyn Methodist Hospital
Brooklyn, New York, United States
RECRUITINGVassar Brothers Medical Center/Nuvance Health
Poughkeepsie, New York, United States
RECRUITING...and 12 more locations